You are here: Home/ Dr. Jean Jacques Kiladjian at ASH 2017, 4 Year Follow up on RESPONSE Trial, a Phase 3 Study Comparing Ruxolitinib with Best Available Therapy for Treatment of Polycythemia Vera

Dr. Jean Jacques Kiladjian at ASH 2017, 4 Year Follow up on RESPONSE Trial, a Phase 3 Study Comparing Ruxolitinib with Best Available Therapy for Treatment of Polycythemia Vera

Fifth in ASH 2017 Series

by David Wallace

This is part 2 of the interview with Dr. Kiladjian. In this segment, we discuss “Results from 4-Year Follow-up of RESPONSE Trial, a Phase 3 Study Comparing Ruxolitinib (Rux) with Best Available Therapy (BAT) for the Treatment of Polycythemia Vera.” Part 1 of the interview can be found here.

Summary of Key Points:

The purpose of the RESPONSE trial is to compare Ruxolitinib to best available treatment (BAT) in Polycythemia Vera (PV) patients that are resistant/intolerant of Hydroxyurea (HU). Findings presented at ASH were on the 4-year (208-week) follow-up.

At 32 weeks, there was shown to be an increase in risk of infection and non-melanoma skin cancer with the use of Ruxolitinib compared to BAT.

It is important to remember that all these patients had previously received long-term HU therapy, which causes skin toxicities.

After 4 years on Ruxolitinib, the incidence of non-melanoma skin cancer was stable, but there was a high correlation in patients that developed skin lesions with those who had a history of lesions before Ruxolitinib treatment.

It is important to monitor patients on long-term Ruxolitinib therapy for skin lesions, especially if they have a history of lesions, of HU treatment, or live in a southern climate.

A common adverse effect of Ruxolitinib is weight gain, which can be beneficial to some patients (especially with Myelofibrosis) who have lost too much weight because of an enlarged spleen.

In PV patients who are not underweight, this weight gain can be troubling, and doctors should be more aware of this adverse effect and try to mange it.

Clinicohematologic response (CLHM) is defined as a combination of complete hematological response on blood counts and a reduction of spleen size. Most patients maintained CLHM at 4 years, showing durable efficacy.

Overall survival rate at 4 years on Ruxolitinib is above 90%, which is encouraging, because PV patients who fail on HU can have a poor prognosis.

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PV Reporter was created by David Wallace, an aspiring web designer, publisher, writer, reporter, patient advocate and chief bottle washer. I have been a PV patient since 2009. PV became a motivating factor to push myself to always be learning something new. Learning web design and becoming a patient advocate were some of my primary goals.

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